FDA KNEW OF VIAGRA BLINDNESS LINK FOR MORE THAN A YEAR

July 27, 2005

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Impotence drugs Viagra, Cialis, Levitra could cause blindness: Health Canada

OTTAWA (CP) - Health Canada is advising men who take drugs for impotence and erectile dysfunction to seek immediate medical attention if they experience vision problems.

Users of Viagra, Cialis and Levitra are at risk of a rare side-effect called nonarteritic anterior ischemic optic neuropathy, or NAION, caused when blood flow to the optic nerve is blocked.

Symptoms include sudden and painless loss of vision in one or both eyes. Those who experience one episode are at greater risk of experiencing a second episode affecting the other eye.

While in some cases the condition may improve over time, it can also be irreversible.

Men older than 50 or those suffering from heart disease, high blood pressure, high cholesterol, diabetes or certain pre-existing eye problems, and smokers, are most at risk.

Health Canada cited an article in the March issue of the Journal of Neuro-Ophthalmology that discussed 14 cases of the eye affliction occurring in patients using Viagra. All the patients had other risk factors, including high blood pressure, high cholesterol or diabetes.

Health Canada is reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with the affliction, but it said it has not yet confirmed whether those problems are related to use of the medications.

"It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing (eye problems), as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk," it said in the statement Tuesday.

Health Canada said it is monitoring the drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer AG/GlaxoSmithKline (Levitra).

"Changes to the product information for health-care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed," said the statement.

Last month, Pfizer Inc. said a review concluded that Viagra doesn't increase patients' risk of blindness but the company was still working with U.S. federal regulators to update the drug's label to reflect rare reports of vision loss.

In May, the U.S. Food and Drug Administration said it had 38 reports of blindness caused by NAION among users of Viagra. It also reported there were instances of the eye affliction among those taking Cialis and Levitra.

Pfizer said it conducted a review of all post-marketing ocular event reports and concluded there is no evidence of increased risk of blindness among patients taking Viagra.

While the FDA concluded that no causal relationship between Viagra and NAION has been established, Pfizer agreed to include on the Viagra label that these reports exist to inform physicians and patients.

Similar U.S. measures were expected with Cialus and Levitra.

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FDA KNEW OF VIAGRA BLINDNESS LINK FOR MORE THAN A YEAR

July 1, 2005 The U.S. Food and Drug Administration (FDA) knew that Pfizer's Viagra had been linked to blindness at least 13 months before a scientific journal reported the risk, Sen. Charles E. Grassley (R-Iowa) alleges.

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Grassley said an FDA safety officer had noted the risk from monitoring adverse event reports and told her supervisors that physicians and the public should be warned. Nothing was done. No public notice was issued and there were no changes to the drug's label.

The series of events is outlined in a letter sent by Grassley to FDA Acting Commission Lester E. Crawford. Grassley said the agency had moved "far too slowly" on identifying and reacting to potential safety issues with the erectile dysfunction drug.

"I am troubled by the FDA's action, or lack thereof, relating to the updating of Viagra's product label," Grassley wrote. He said it was the latest example of inaction involving the FDA's Office of New Drugs (OND).

The FDA has come under fire for failing to alert consumers to potential risks in drugs including Merck's popular painkiller Vioxx, pulled from the market last fire.

The Viagra blindness risk was reported late last month in the Journal of Neuro-Ophthalmology. The journal study examined seven cases where men suffered an unusual form of sudden blindness within 36 hours of taking Viagra.

The rare form of sudden blindness -- non-arteritic anterior ischemic optic neuropathy, or NAION -- is caused by the blockage of blood flow to the optic nerve and is most common in older people, who are the predominant users of Viagra. An estimated 1,000 to 6,000 Americans suffer an optic blockage each year.

Pfizer, meanwhile, denies a connection between Viagra and NAION. In a statement, the company said that problems that can lead to erectile dysfunction tend to be risk factors for NAION as well.

"After more than 10 years of rigorous clinical study and worldwide safety monitoring of a medicine used by more than 27 million men, there is no evidence to suggest a link between Viagra and blindness or other serious ocular events," said Dr. Joseph Feczko, Pfizer's chief medical officer.

The FDA said that 38 Viagra users and five users of other impotence drugs suffered NAION attacks. But in a report Monday, CBS News said the number is much higher, and that more than 800 patients and doctors have reported eye problems to the FDA after using Viagra over the past four years, with more than 140 cases of partial or total blindness.

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